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United States · US · US:68071-4224_440bc10d-a2fd-a450-e063-6394a90aabfe
AMOXICILLIN AND CLAVULANATE POTASSIUM
Orange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680714224220 TABLET, FILM COATED in 1 BOTTLE (68071-4224-2)
Annotations
UNII (FDA Substance ID)
804826J2HU
AMOXICILLIN
RxCUI 133008
Orange Book
A204755
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "804826J2HU",
"rxcui": "133008",
"inchikey": "MQXQVCLAUDMCEF-CWLIKTDRSA-N",
"display_name": "AMOXICILLIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"263a2902-f85c-46b6-8d5b-8c99f5c4b706": {
"match": "brand_token",
"title": "AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "68071-4224_440bc10d-a2fd-a450-e063-6394a90aabfe",
"productndc": "68071-4224",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "204755",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "875MG;EQ 125MG BASE",
"product_no": "003",
"approval_date": "Dec 30, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"proprietary_name": "AMOXICILLIN AND CLAVULANATE POTASSIUM",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA204755",
"marketing_category": "ANDA",
"nonproprietary_name": "Amoxicillin and Clavulanate Potassium",
"start_marketing_date": "20170301",
"active_numerator_strength": "875; 125"
}Related drugs
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